MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number 180343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 07/10/2020

Event Type  Injury  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A peritoneal dialysis (pd) patient contacted technical support to report that they were in the hospital because their replacement cycler did not arrive on time, and they could not complete dialysis on a cycler for 3 days in a row.The patient was unable to complete treatments on the cycler from (b)(6) 2020.There were no changes to the patient's health status and no long term issues as a result of the reported event.The patient missed a total of 3 days of treatment, and as a result the patient went to the hospital on (b)(6) 2020 and had dialysis performed.The patient's nurse reported that there were issues with the replacement cycler not arriving on time.It was determined on (b)(6) 2020 that the old cycler was not working at setup.The patient was told over the phone that a new cycler would be there by 8pm on (b)(6) 2020, but it never came.On (b)(6) 2020, the patient called technical services from their hospital room to see if it was arriving soon, but no one knew what they were talking about.Next, they were told that a replacement would arrive on (b)(6) 2020 by 8 pm and it never arrived.The nurse had to go to the patient's home to help them do manuals, and the new cycler arrived on (b)(6) 2020.It was confirmed the patient did not experience an adverse event or require medical intervention as a result of the missed pd treatment.Though the hospitalization was due to the unavailability of a cycler, the initial reason for the hospital visit was not due to a deficiency or malfunction of the liberty select cycler or any fresenius device(s) or product(s).The patient continues pd therapy on a newly received liberty select cycler at home with no reported adverse events.Clinical investigation: on (b)(6) 2020, during a follow up, a peritoneal dialysis registered nurse (pdrn) reported to fresenius that the patient was hospitalized.There was an inferred allegation the hospitalization was related to the unavailability of a liberty select cycler in the follow up.Upon follow up, the patient¿s pdrn reported the patient was hospitalized for a planned, nonemergent blood transfusion on (b)(6) 2020 that was unrelated to pd therapy.The patient had recently ordered a new liberty select cycler that had a targeted delivery date of (b)(6) 2020.The cycler was not received on the expected date and the patient was held in the hospital to undergo a pd treatment on a hospital provided cycler and products (not fresenius products) the night of (b)(6) 2020.It was confirmed the overnight hospital stay was directly attributed to the new liberty select cycler not being delivered in the anticipated timeframe.The patient was discharged on (b)(6) 2020 and did not undergo a pd treatment that night due to the unavailability of a cycler.The patient was provided a manual exchange at home in the evening of (b)(6) 2020 by the pdrn.It was confirmed the patient did not experience an adverse event or require medical intervention as a result of the missed pd treatment.Though the hospitalization was due to the unavailability of a cycler, the initial reason for the hospital visit was not due to a deficiency or malfunction of the liberty select cycler or any fresenius device(s) or product(s).The patient continues ccpd therapy on a newly received liberty select cycler at home with no reported adverse events.Based on the available information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.

Manufacturer Narrative

Correction: a2.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 10356911
• MDR Text Key: 201542243
• Report Number: 2937457-2020-01385
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR